Technol, Maintenance (2nd Shift)

Edwards Lifesciences; Salt Lake City (UT); On-site; USD 65,000 - 90,000; Full time

Job summary

Edwards Lifesciences in Salt Lake City, Utah, is hiring for a full-time Maintenance/Equipment Validation role to support Operations and Engineering. You will troubleshoot, validate, and improve automation and manufacturing equipment while ensuring regulatory documentation is complete and accurate.

The position requires hands-on maintenance, strong problem-solving, and collaboration with Quality and Engineering. A technical background in manufacturing equipment and GMP practices is preferred.

Qualifications

• Must have strong written and verbal communication skills.
• Experience with GMP/Good Documentation Practices.
• Proficient with MS Office; CAD skills a plus.
• Experience in manufacturing/medical device environments preferred.

Responsibilities

• Troubleshoot and maintain equipment to limit downtime and support validation.
• Design, set-up and execute feasibility studies and tests to improve equipment and processes.
• Lead projects related to new equipment validation and investigations.
• Perform preventive maintenance on complex equipment and document actions.
• Collaborate with Quality to implement corrective actions and non-conformance reports.
• Validate equipment documentation and transfer information to appropriate systems.

Skills

Communication

Problem solving

GDP (GxP)

Documentation

Project basics

Troubleshooting

Education

High School Diploma or equivalent

Associate's Degree or equivalent

Tools

JDE

QMS

PLM

CAD

Job description

USA - Utah – Salt Lake City

Full time

Req-50807

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Technol position is a unique career opportunity that could be your next step towards an exciting future.

Provides technical and function-specific knowledge to support Operations and Engineering activities.

Key Responsibilities:

• Troubleshoot and recommend maintenance to limit downtime, to keep production on schedule, and to ensure ongoing validation compliance
• Design, set-up and execute feasibility studies, experiments, and tests - both creating and following established protocols - to develop findings for the validation and improvement of equipment and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports for Engineering review
• Lead projects related to new equipment validation, equipment investigations, testing, objective evidence of product dispositions and rework
• Perform both scheduled and unscheduled preventive maintenance routines on a wider range of complex equipment to validate user operation and avoid program down time
• Check for failures in more complex equipment and processes, and perform corrective actions to affected areas that have down time, including conducting and writing impact assessment reports of incidents
• Collaborate with Quality in devising and implementing corrective actions, exception work orders (EWOs), Equipment Non-conformance Reports (ENCRs), and Out of Tolerance (OOTs)
• Review documentation and take appropriate actions to ensure that information is appropriately catalogued and follow through to validation and qualification of equipment, including transferring information to appropriate locations, e.g., ECRs, SOPs, drawings, and tooling, for Engineering approval
• Utilize manufacturing software (e.g., JDE, QMS,PLM) to update documentation in systems
• Collaborate with Engineering and CAD/Designers to develop new basic tools
• Provide coaching and guidance to technicians
• On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period
• Other incidental duties (e.g. occasional photo copying or deliveries)

Education and Experience:

• H.S. Diploma or equivalent 6 Years related experience Required or
• Associate's Degree or equivalent 4 Years related experience Required
• previous experience in manufacturing and/or medical device experience Preferred

Additional Skills:

• Strong written and verbal communication, interpersonal, and relationship building skills
• Problem solving methodology, root cause analysis, and GDP (Good Documentation Practices)
• Strong computer skills, including usage of MS Office Suite; and CAD if applicable
• Full knowledge of validation and improvement of automated equipment
• Ability to troubleshoot manufacturing equipment
• Knowledge of material compatibility in the proposed use environment
• Ability to understand the fundamentals of project management
• Full knowledge of routine preventive maintenance of production equipment
• Full knowledge electrical, mechanical, electronic, pneumatic, and controls
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
• Strict attention to detail
• Must be able to work with other departments including formulating work instructions and providing guidance and training to lower-level employees with little to no direction
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.